# K101502: BD Vacutainer Rapid Serum Tube Blood Collection Tube, Model 368774

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jun 29, 2010 after 28 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Vacutainer SST Plus Blood Collection Tube: named in the summary without a submission number

## Indications for use
The BD Vacutainer® Rapid Serum Tube Blood Collection Tube with HemogardTM Closure (BD RST HG) is a single use tube used to collect, separate, transport and process venous blood specimens to obtain serum for chemistry determinations for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker. Clot time has not been established for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency. As a result, the use of BD RST HG in these patients is not recommended.

Source page: https://510kreport.com/device/K101502
Methodology: https://510kreport.com/methodology